JUMISO NO PAIN NO GAIN AC CURE SPOT- salicylic acid cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)
Available from:
HELLO SKIN Co.,Ltd.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Treatment For the treatment of Acne
Authorization status:
OTC monograph final
Authorization number:
73058-001-01, 73058-001-02

JUMISO NO PAIN NO GAIN AC CURE SPOT- salicylic acid cream

HELLO SKIN Co.,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

73058-001

Salicylic Acid 0.01%

Acne Treatment

For the treatment of Acne

Following facial cleansing, dispense a small amount onto a clean finger and apply on the desired area,

evenly massaging contents into the skin to aid absorption.

For external use only

When using this product, skin irritation and dryness is more likely to occur if you use another topical

acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

avoid contact with eyes. If contact occurs, flush thoroughly with water.

People with allergy to aspirin will react poorly to the Salicylic Acid.

Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control

center right away.

Water, Butylene Glycol, Silica, Niacinamide, Glycerin, Lithospermum Erythrorhizon Root Oil,

Caprylic/Capric Triglyceride, Glyceryl Stearate, Macadamia Integrifolia Seed Oil, Carthamus

Tinctorius (Safflower) Seed Oil, Limnanthes Alba (Meadowfoam) Seed Oil, Argania Spinosa Kernel

Oil, Sodium Hyaluronate, Orbignya Oleifera Seed Oil, Glyceryl Stearate, PEG-100 Stearate,

Polysorbate 60, Cetearyl Alcohol, Belamcanda Chinensis Root Extract, Sorbitan Monostearate,

Propylene Glycol, Octanediol, Stearic acid, Bacopa Monniera Extract, Carbomer, Melaleuca

Alternifolia (Tea Tree) Leaf Oil, Triethanolamine, 1,2-Hexandiol, Ethylhexylglycerin, Allantoin,

Dimethyl Sulfone, Alcohol, Phellodendron Amurense Bark Extract, Coptis Chinensis Root Extract,

Aloe Barbadensis Leaf Extract, Luffa Cylindrica Fruit Extract, Citrus grandis (grapefruit) seed extract,

Tocopheryl Acetate, Centella Asiatica Extract, Dipotassium Glycyrrhizate, Polyglutamic acid,

Tocopherol, Hydrogenated Lecithin, Adenosine, Ceramide NP, Disodium EDTA, Camellia Sinensis

Leaf Extract, Polygonum Cuspidatum Root Extract, Scutellaria Baicalensis Root Extract, Maltodextrin /

Sodium Starch Octenylsuccinate, Rosmarinus Officinalis (Rosemary) Leaf Extract, PEG-10 Rapeseed

sterol, Hydroxyethylcellulose, Citrus Aurantium Bergamia (Bergamot) Leaf Extract, Lavandula

Angustifolia (Lavender) Flower Extract, Rosa Centifolia Flower Extract, Glycyrrhiza Glabra (Licorice)

Root Extract, Calcium Pantothenate, Artemisia princeps extract, Dipropylene Glycol, Methionine,

Serine, Histidine, Hydroxyethylethylcelluose, Chamomilla Recutita (matricaria) Flower Extract, Sodium

Ascorbyl Phosphate, Glyceryl Stearate, Glycereth-20, Portulaca Oleracea Extract, Dryopteris Filix-

Mas Root Extract, Phenoxyethanol, Pyridoxine HCl

JUMISO NO PAIN NO GAIN AC CURE SPOT

salicylic acid cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:730 58 -0 0 1

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)

SALICYLIC ACID

0 .0 0 15 g in 15 g

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4)

NIACINAMIDE (UNII: 25X51I8 RD4)

GLYCERIN (UNII: PDC6 A3C0 OX)

LITHO SPERMUM ERYTHRO RHIZO N RO O T (UNII: 9 I70 D8 O47I)

MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9 H2L21V7U)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

MACADAMIA O IL (UNII: 5156 10 SU8 C)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

MEADO WFO AM SEED O IL (UNII: 412ZHA4T4Y)

ARGAN O IL (UNII: 4V59 G5UW9 X)

HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH)

BABASSU O IL (UNII: 8 QSB4M5477)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

IRIS DO MESTICA RO O T (UNII: T2MU9 QFA8 7)

SO RBITAN MO NO STEARATE (UNII: NVZ4I0 H58 X)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

O CTANEDIO L (UNII: 8 0 6 K32R50 Z)

STEARIC ACID (UNII: 4ELV7Z6 5AP)

TEA TREE O IL (UNII: VIF56 5UC2G)

TRO LAMINE (UNII: 9 O3K9 3S3TK)

1,2 -HEXANEDIO L (UNII: TR0 46 Y3K1G)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

ALLANTO IN (UNII: 344S277G0 Z)

DIMETHYL SULFO NE (UNII: 9 H4PO4Z4FT)

ALCO HO L (UNII: 3K9 9 58 V9 0 M)

PHELLO DENDRO N AMURENSE BARK (UNII: PBG27B754G)

CO PTIS CHINENSIS RO O T (UNII: CXS4LJR7EL)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

LUFFA AEGYPTIACA FRUIT (UNII: QKL9 NEO1F9 )

CITRUS MAXIMA SEED (UNII: 0 8 3X55C543)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

CENTELLA ASIATICA (UNII: 7M8 6 7G6 T1U)

GLYCYRRHIZINATE DIPO TASSIUM (UNII: CA2Y0 FE3FX)

PO LYGALIC ACID (UNII: XCC6 WEA55L)

TO CO PHERO L (UNII: R0 ZB2556 P8 )

HYDRO GENATED SO YBEAN LECITHIN (UNII: H110 9 Z9 J4N)

HELLO SKIN Co.,Ltd.

ADENO SINE (UNII: K72T3FS56 7)

CERAMIDE NP (UNII: 4370 DF0 50 B)

EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)

GREEN TEA LEAF (UNII: W2ZU1RY8 B0 )

REYNO UTRIA JAPO NICA RO O T (UNII: 7TRV45YZF7)

SCUTELLARIA BAICALENSIS RO O T (UNII: 7J9 5K7ID2S)

RO SEMARY (UNII: IJ6 7X351P9 )

PEG-10 RAPESEED STERO L (UNII: 258 O76 T8 5M)

HYDRO XYETHYL CELLULO SE ( 10 0 MPA.S AT 2 %) (UNII: R33S7TK2EP)

CITRUS BERGAMIA LEAF (UNII: ZGS9 6 VDV4T)

LAVANDULA ANGUSTIFO LIA SUBSP. ANGUSTIFO LIA FLO WER (UNII: 19 AH1RAF4M)

RO SA CENTIFO LIA FLO WER (UNII: CS4TE8 FF7O)

GLYCYRRHIZA GLABRA (UNII: 278 8 Z9 758 H)

CALCIUM PANTO THENATE (UNII: 56 8 ET8 0 C3D)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:730 58 -0 0 1-0 2 1 in 1 PACKAGE

0 4/18 /20 19

1

NDC:730 58 -0 0 1-0 1 15 g in 1 CONTAINER; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt333D

0 4/18 /20 19

Labeler -

HELLO SKIN Co.,Ltd. (694804812)

Registrant -

HELLO SKIN Co.,Ltd. (694804812)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

MICELL KOREA LAB CO., LTD

6 8 9 8 51542

ma nufa c ture (730 58 -0 0 1)

Revised: 4/2019

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